NCT01067222

Brief Summary

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

February 9, 2010

Last Update Submit

June 8, 2012

Conditions

NarcolepsyExcessive Daytime SleepinessCataplexySleep Disorders

Keywords

NarcolepsyExcessive daytime SleepinessCataplexySleep DisordersSleep attacksOrphan DrugPitolisant

Outcome Measures

Primary Outcomes (1)

  • Epworth Sleepiness Scale (ESS)

    between baseline and at the end of 8 week DB phase

Secondary Outcomes (2)

  • Sleep Diary: Number and duration of diurnal sleep and sleepiness episodes, number of cataplexy attacks

    14 days before randomization and 7 days before each visit

  • Maintenance of Wakefulness Test (MWT), Test of Sustained Attention to Response Task (SART).

    at inclusion and after 8-week treatment

Study Arms (3)

BF2.649

EXPERIMENTAL
Drug: BF2.649

Modafinil

ACTIVE COMPARATOR
Drug: Modafinil

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BF2.649DRUG

BF2.649 oral capsules at 10 or 20 or 40 mg per day

Also known as: Pitolisant
BF2.649
ModafinilDRUG

Modafinil oral capsules at 100 or 200 or 400 mg per day

Also known as: Modiodal
Modafinil
PlaceboDRUG

Placebo oral capsules, 4 capsules per day

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of narcolepsy with or without cataplexy
  • patients need to free of or discontinue psychostimulant medications for at least 14 days,
  • patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
  • patients must have adequate support to comply with the entire study requirements

You may not qualify if:

  • Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
  • Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
  • Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
  • Current or recent history of a substance abuse or dependence disorder including alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurocenter (EOC) of Southern Switzerland

Lugano, 6903, Switzerland

Location

Related Publications (3)

  • Meskill GJ, Davis CW, Zarycranski D, Doliba M, Schwartz JC, Dayno JM. Clinical Impact of Pitolisant on Excessive Daytime Sleepiness and Cataplexy in Adults With Narcolepsy: An Analysis of Randomized Placebo-Controlled Trials. CNS Drugs. 2022 Jan;36(1):61-69. doi: 10.1007/s40263-021-00886-x. Epub 2021 Dec 21.

    PMID: 34935103DERIVED

  • Watson NF, Davis CW, Zarycranski D, Vaughn B, Dayno JM, Dauvilliers Y, Schwartz JC. Time to Onset of Response to Pitolisant for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy: An Analysis of Randomized, Placebo-Controlled Trials. CNS Drugs. 2021 Dec;35(12):1303-1315. doi: 10.1007/s40263-021-00866-1. Epub 2021 Nov 25.

    PMID: 34822113DERIVED

  • Dauvilliers Y, Bassetti C, Lammers GJ, Arnulf I, Mayer G, Rodenbeck A, Lehert P, Ding CL, Lecomte JM, Schwartz JC; HARMONY I study group. Pitolisant versus placebo or modafinil in patients with narcolepsy: a double-blind, randomised trial. Lancet Neurol. 2013 Nov;12(11):1068-75. doi: 10.1016/S1474-4422(13)70225-4. Epub 2013 Oct 7.

    PMID: 24107292DERIVED

MeSH Terms

Conditions

NarcolepsyDisorders of Excessive SomnolenceCataplexySleep Wake Disorders

Interventions

pitolisantModafinil

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Claudio Bassetti

    Neurocenter (EOC) of Southern Switzerland, Lugano, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2010

First Posted

February 11, 2010

Study Start

May 1, 2009

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

CH(1)